AVIPure dsRNA Clear OPUS Columns

Improve mRNA product purity

Superior mRNA therapeutics with precise dsRNA removal

Efficient removal of dsRNA is essential to ensure the safety and efficacy of mRNA biotherapeutics. AVIPure dsRNA Clear affinity resin prepacked in OPUS columns has emerged as a highly effective solution for this challenge, offering precise and reliable separation of dsRNA from single-stranded RNA (ssRNA). By leveraging specific binding interactions, affinity chromatography enhances the purity and quality of RNA-based therapeutics, ultimately contributing to their success in clinical applications.

AVIPure dsRNA Clear is the first and only bead based, affinity chromatography solution for removing dsRNA impurities from mRNA preparations. The solution is targeted, eliminates the use of organic solvents (EtOH), negates the need for a non-specific and non-scalable removal methods and sets the standard for dsRNA impurity clearance in mRNA production processes.

Chromatogram showing dsRNA depleted flow through.

製品の性能

Optimized dsRNA clearance for therapeutic success

To help scientists to accelerate therapeutic development, AVIPure dsRNA Clear OPUS columns are designed to remove double stranded RNA from complex feedstocks via affinity chromatography. The resin enables users to maintain high target molecule recovery while eliminating dsRNA from the feedstock. Easily scale from process development to clinical and commercial manufacturing using this resin, which is available exclusively in OPUS pre-packed chromatography columns.

The highest clearance of dsRNA, typically two to three log reduction, is observed with optimized IVT feeds with already low dsRNA levels where RNA presents as a single, sharp band on a gel. Even in unoptimized feeds with higher dsRNA content, or where RNA appears as a smear or ladder on a gel, users are able to achieve a few fold reduction of dsRNA.

Performance and Efficiency

• High Dynamic Binding Capacity: ≥0.4 mg dsRNA/mL_{column volume} at 10% breakthrough
• Selectivity: Resin selectively binds double stranded RNA in high salt (>0.5 M NaCl) from pH 7.2-9.5 for easily impurity removal. mRNA, circular RNA, and self-amplifying RNA flows through.
• Purity and Yield: Superior product purity and yield, delivering excellent target molecule recovery with limited product loss

Regulatory Compliance and Safety

• Compliance with Industry Standards: Large scale columns are ready for use in GMP processing.
• Biocompatibility and Safety: AVIPure dsRNA Clear OPUS columns are free from animal derived components. Residual ligand ELISA kit available for detection of leached ligand.

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An immuno-northern technique to measure the size of dsRNA byproduct in in vitro transcribed RNA

This article describes a method for determining the sizes of dsRNA byproducts in mRNA feed streams. Understanding the sizes of dsRNA contaminants is crucial to designing strategies for reducing and removing dsRNA from mRNA, circRNA, and saRNA drug substances. These byproducts, however, are a minor fraction of the total RNA in feeds, and dsRNA sizes cannot be measured with any current analytical techniques. Scientists developed this method during the product development of AVIPure dsRNA Clear, an innovative affinity resin that that removes dsRNA from mRNA feeds in a fast, simple, flow-though operation that requires no organic solvents.

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